Analytical procedure for quality control of 18F-Choline radiopharmaceutical

Abstract

¹⁸Fluoromethylcholine (¹⁸F-Choline, ¹⁸F-FCH) has been produced using a home-made automatic synthesiser at 30 MeV Cyclotron Centre, 108 Military Central Hospital. In order to be licensed using for patients, the ¹⁸F-FCH radiopharmaceutical needs to meet the required quality specifications listed in the pharmacopeia. The objective of this study was to build up the analytical procedure and to perform for the ¹⁸F-FCH quality control followed the EuPh2017 pharmacopeia for the PET radiopharmaceutical. The result obtained confirmed that the total time to complete the test of one sample of the ¹⁸F-FCH was less than 35 min. Identifications of ¹⁸F-FCH, radiochemical purity, and ¹⁸F content were determined with accuracy >96% by High-performance liquid chromatography (HPLC) method and content of residual solvents consists of Ethanol, Acetonitrile, Dibromomethane, Dimethylethanolamine were determined with the accuracy >97% by Gas chromatography (GC) method.